ACS CDCR07DRecalls & reported problems
American Contract Systems, Inc. · CMC CRANIOTOMY · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072046062), received between Sep 20, 2019 and Sep 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2019Device Contamination with Chemical or Other Material
HAIR FOUND IN PACK ON CONTROL SYRINGE (CONTROL SYRINGE WAS IN THE BLUE BASIN). STERILE FIELD TORN DOWN. SURGEONS NOTIFIED. NEW PACK AND NEW TRAYS OF INSTRUMENTS WERE OPENED. HAIR WAS NOT SAVED. HAIR DESCRIBED AS SHORT (1-1.5CM LENGTH) AND BLACK/DARK BROWN. NO SHAVE OF PATIENT IN OR ROOM. EVENT CREATED OR DELAY. PACKING LIST FOR PACK SAVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9097385 ↗
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- Medline Industries, Inc. CDS983467JMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. ACC010690Medline Industries, Inc. · General surgery tray4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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